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NCT05014919 · ClinicalTrials.gov registry record · Phase 3
Vortioxetine to Prevent Return of Symptoms in Children With Depression
A Phase 3 study, sponsored by H. Lundbeck A/S.
- Terminated
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
NCT05014919: Clinical Trial Phase 3 study, sponsored by H. Lundbeck A/S.
NCT05014919 is a Phase 3 study that was terminated before completion, run by H. Lundbeck A/S. The registered enrollment target is 35 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05014919, a Phase 3 study, was terminated before completion, sponsored by H. Lundbeck A/S.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
Study Summary
The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills) in preventing depression in children who improved when treated with vortioxetine.
Primary Outcome
Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items
Interventions
- DRUG Placebo
- DRUG Vortioxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2021-08-10 |
| Est. Completion | 2022-04-28 |
| Phase | Phase 3 |
Why NCT05014919 stopped before completion
NCT05014919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05014919 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05014919 about?
NCT05014919 is a clinical study titled "Vortioxetine to Prevent Return of Symptoms in Children With Depression". The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills) in preventing depression in children who improved when treated with vortioxetine.
What is the current status of trial NCT05014919?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2021-08-10. Estimated completion is 2022-04-28.
What interventions are being tested in trial NCT05014919?
The interventions under investigation include: Placebo (DRUG), Vortioxetine (DRUG).
Who is sponsoring clinical trial NCT05014919?
This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05014919's enrollment target sits among peer trials
35 1903rd of 2000 higher than 96 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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